SaMD

Software as a Medical Device (SaMD) refers to software applications that are intended for medical purposes but are not part of a hardware medical device. SaMD can perform functions such as diagnosing diseases, analyzing medical data, or providing treatment recommendations based on algorithms. The regulatory framework for SaMD is defined by the International Medical Device Regulators Forum (IMDRF) and varies by jurisdiction, with the FDA providing specific guidelines for SaMD in the United States. SaMD must undergo rigorous validation processes to ensure safety and effectiveness, often requiring clinical evidence to support its intended use. The classification of SaMD is based on the level of risk associated with its use, which influences the regulatory pathway and requirements for market entry. As AI technologies evolve, the definition and scope of SaMD continue to expand, necessitating ongoing regulatory adaptation.